Expert Rev Vaccines. 2021 Oct 21. doi: 10.1080/14760584.2021.1994858. Online ahead of print.
ABSTRACT
BACKGROUND: : V114 (15-valent pneumococcal conjugate vaccine [PCV15]) and a 20-valent PCV (PCV20) are approved for adults (≥18 years of age) in the United States. We present methodologies to indirectly compare immune responses to V114 versus PCV20.
RESEARCH DESIGN AND METHODS: : Indirect treatment comparison and matching-adjusted indirect comparison (MAIC) were performed to estimate immune responses to V114 and PCV20 for 13 serotypes (STs) shared with a 13-valent PCV (PCV13) among pneumococcal-vaccine naïve adults aged ≥60 years. Data from three V114 studies were pooled (V114, N=2,196; PCV13, N=843). In the MAIC analysis, data were reweighted, matching participant age and sex in NCT03760146 (PCV20, N=1,507; PCV13, N=1,490). Opsonophagocytic activity (OPA) geometric mean titer (GMT) ratios of V114/PCV20 at 30 days post-vaccination used PCV13 as common comparator.
RESULTS: : V114 was non-inferior to PCV20 (lower bound of OPA GMT ratio V114/PCV20 >0.5) for all PCV13 STs and statistically superior (lower bound of OPA GMT ratio V114/PCV20 >1.2) for five STs (3, 6A, 6B, 18C, and 23F) shared with PCV13. V114 was associated with 77% greater OPA GMT for ST3 versus PCV20.
CONCLUSION: : V114 was non-inferior to PCV20 for all PCV13 STs and statistically superior for five STs covered in all three vaccines.
PMID:34672224 | DOI:10.1080/14760584.2021.1994858
